BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 17737209 · Received September 13, 2023

    Report

    Report Number
    2029214-2023-01689
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    May 9, 2023
    Report Date
    September 13, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. SEE ATTACHED LITERATURE ARTICLE. NO SPECIFIC DEVICE INFORMATION RECEIVED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LU, J., ZHAO, Y., ZHANG, H., LI, T., SONG, D., GUAN, S., MAIMAITILI, A., WANG, Y., FENG, W., WANG, Y., WAN,J., MAO, G., SHI, H., YANG, X., LIU, J., ZHAO, Y. LEARNING CURVE IN PIPELINE EMBOLIZATION DEVICE: RESULTS FROM THE PIPELINE EMBOLIZATION DEVICE IN CHINA POST-MARKET MULTICENTRE REGISTRY STUDY. INTERNATIONAL JOURNAL OF SURGERY. 2023. 109:2159¿2167. DOI: 10.1097/JS9.0000000000000467. SUMMARY: INTRACRANIAL ANEURYSMS POSE A SIGNIFICANT HEALTH ISSUE, AFFECTING 3¿5% OF THE ADULT POPULATION. THE PIPELINE EMBOLIZATION DEVICE (PED) HAS EMERGED AS A PROMISING TREATMENT FOR THESE LESIONS. THIS STUDY AIMED TO INVESTIGATE THE IMPACT OF OPERATOR EXPERIENCE ON COMPLICATION AND POOR OUTCOME RATES, AS WELL AS THE LEARNING CURVE FOR PED. A TOTAL OF 217 PATIENTS WERE CONSECUTIVELY ENROLED FROM FOUR ELIGIBLE CENTRES AND DIVIDED INTO THREE GROUPS BASED ON THE NUMBER OF PROCEDURES PERFORMED: GROUP 1 (FIRST 10 PROCEDURES), GROUP 2 (11¿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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89105 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention